Commissioning Engineer - CQV

Location: Dublin (fully on-site role)
Contract: 5-6 Months

Rate: €75.00 per hour

Job Function

Working in association with the Area CQV Lead, prepare and execute site commissioning and validation testing for equipment and utilities at a sterile drug product manufacturing facility, in alignment with site and global procedures.

Responsibilities

• Develop and execute CQV testing documentation for benchtop equipment and manual inspection booths within the sterile drug product facility.
• Meet key project deliverables for safety, CQV schedule, and quality of project-related documentation and electronic records for assigned equipment and utilities.
• Ensure GMP equipment is tested in compliance with good manufacturing practices, company policies, and EU & FDA regulations.
• Ensure all equipment is tested in compliance with relevant project standards from a commissioning perspective.
• Manage deviations associated with assigned equipment and utilities.
• Identify and categorise CQV risks according to their impact on commissioning and qualification; generate action plans to mitigate qualification risks.
• Execute FAT testing and leverage results into the overall qualification process for assigned equipment, facilities, and utilities.
• Complete all assigned training on time to meet site metrics.

Required Qualifications and Experience

• Minimum of a BS (Degree) in a scientific, technical, or engineering discipline.
• Minimum of 5 years' experience within the pharmaceutical industry, ideally with familiarity in sterile drug product filling line experience.
• Demonstrable capacity to effectively execute the CQV testing approach for assigned equipment, from initiation to completion.
• CQV project lifecycle experience, from design through to C&Q and handover.
• Demonstrable experience working as part of a diverse team of CQV professionals and contractors, delivering tasks safely, on time, within budget, and with a strong quality focus.
• Experience in CQV of drug substance/drug product sterile manufacturing equipment with integrated automation.
• Solid background in document preparation, execution, and task planning on CQV projects, with a demonstrated record of on-time delivery.
• Excellent communication skills and the ability to influence others.
• Demonstrable experience working in teams within a matrix environment to deliver CQV elements.
• Previous experience with an electronic validation platform (e.g. ValGenesis, Kneat) is desirable.